Luteal Phase Support With Progesterone Versus Estrogen and Progesterone on Pregnancy Rates

Luteal Phase Support With Progesterone vs Estrogen and Progesterone on Pregnancy Rates in Ovarian Stimulation and Intrauterine Insemination Cycles: a Prospective Randomized Study

This is a single center, 3 arms, prospective randomized controlled open study to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor.

Patients will be randomized into 3 groups:

1. Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)
2. Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].
3. No luteal support

Study Overview

• Status: Unknown
• Conditions: Unexplained Infertility; Mild Male Factor
• Intervention / Treatment: Drug: Luteal support with progesterone only; Drug: Luteal support with estrogen + progesterone; Procedure: Insemination without luteal support

Detailed Description

Study design:

single center, 3 arms, prospective randomized controlled open study

Objective:

to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor.

Methods:

All patients in all study groups will undergo a single insemination procedure and then will be randomized into 3 groups:

1. Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)
2. Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].
3. No luteal support

Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived. A pregnancy test will be performed 2 weeks after insemination (Serum hCG) an intrauterine pregnancy will be confirmed using a transvaginal ultrasound 2 weeks after a positive pregnancy test. If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Galia Oron; Phone Number: 972-3-9377492; Email: orong@clalit.org.il

Study Locations

• Israel
  • Petach-Tikva, Israel, 49202
    • Rabin Medical Center
    • Contact: Galia Oron, Dr; Phone Number: 972-3-9377492; Email: orong@clalit.org.il
    • Principal Investigator: Galia Oron, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Couples with diagnosis of unexplained infertility
2. In their treatment cycle with ovarian stimulation and IUI using recombinant FSH in our institution.

Exclusion Criteria:

1. female partners with one or more of the following:

   • previous ovarian surgery
   • one ovary
   • polycystic ovaries on ultrasound examination
   • other endocrine abnormalities (i.e., polycystic ovarian syndrome, thyroid disorders,hyperprolactinemia,6.hypogonadotropic hypogonadism)
   • past ovarian hyperstimulation or hyperstimulation during the study period
   • diminished ovarian reserve (basal FSH level >15 IU/mL)
   • age of >40 years
2. sever male factor < 5 million total motile sperm on the day of insemination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Luteal support with progesterone only; Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.	Drug: Luteal support with progesterone only; Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel).Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
EXPERIMENTAL: Luteal support with estrogen + progesterone; Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].	Drug: Luteal support with estrogen + progesterone; Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
NO_INTERVENTION: No luteal support	Procedure: Insemination without luteal support; Routine insemination procedure without luteal support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pregnancy	A pregnancy test will be performed 2 weeks after insemination (Serum hCG) an intrauterine pregnancy will be confirmed using a transvaginal ultrasound 2 weeks after a positive pregnancy test	4 weeks after insemintation

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Galia Oron, Dr, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ANTICIPATED): November 1, 2013
• Study Completion (ANTICIPATED): November 1, 2013

Study Registration Dates

• First Submitted: November 8, 2010
• First Submitted That Met QC Criteria: November 8, 2010
• First Posted (ESTIMATE): November 9, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 9, 2010
• Last Update Submitted That Met QC Criteria: November 8, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Insemination; Ovarian stimulation; Luteal phase support; Unexplained infertility
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone; Estrogens
• Other Study ID Numbers: rmc005788ctil